This study will examine people who have pain or fatigue symptoms with a known or unknown diagnosis to determine eligibility for other research studies. No treatment is offered under this protocol.

People 18 years of age or older with symptoms of pain and fatigue may be eligible for this study. Participants undergo standard examinations needed to diagnose or evaluate their symptoms. The results of the test are used to screen subjects for possible participation in other Nursing Institute studies. The study requires from one to three visits at NIH over 12 months for procedures that may include the following:

Medical history, physical examination and questionnaires related to symptoms and quality of life.

Blood tests

Electrocardiogram

Tender point testing. Pressure is applied to areas of the shoulder, hip, neck, chest, elbow and knee to identify tenderness.

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

To facilitate patient recruitment to National Institute of Nursing Research (NINR) clinical research studies on chronic pain and fatigue syndromes.

Estimated Enrollment:

1000

Study Start Date:

May 2008

Detailed Description:

This screening protocol is designed to facilitate patient recruitment to the National Institute of Nursing Research (NINR) clinical research studies on pain and fatigue syndromes. This protocol will also validate the newly developed Saligan Fatigue Questionnaire. Patients must meet the specific requirements of an IRB-approved research study; this protocol serves as a first step for evaluating patients for possible inclusion in a natural history or intervention protocol.

Candidates will be screened with medical history/physical examination, routine laboratory tests, and questionnaires. The physical examination may include the standardized tender point assessment as specified in the American College of Rheumatology (ACR) to diagnose fibromyalgia, measurements of pain (allodynia, hyperalgesia, and hyperpathia), edema, autonomic dysfunction (altered skin color, temperature, or sudomotor activity), and extent of musculoskeletal dysfunction. It will also assess the patients level of pain, fatigue, and quality of life by providing questionnaires for the patients to complete. When the screening is completed, patients will be informed of their options to participate in other NINR interventional or observational clinical research studies. Patients who are not eligible for these studies will be informed of alternative treatments. No treatment is offered under this protocol. Information collected in this protocol will be used to determine eligibility to other NINR protocols.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

INCLUSION CRITERIA:

To be included, patients must meet all of the following:

Are greater than or equal to 18 years of age;

Have symptoms of pain and/or fatigue.

EXCLUSION CRITERIA:

Patients with any one of the following will be excluded:

Inability to provide informed consent for the study;

Are unwilling or unable to cooperate with the study procedures or travel to NIH for the procedures.

In addition to the above criteria, participants with the following conditions will be excluded from the participating in the peak exercise testing:

Any medical condition that limits exercise performance and/or affects participants safety during exercise. This includes diseases of the cardiovascular, pulmonary, neurological, metabolic or musculoskeletal systems such as:

On medications that would influence aerobic capacity or treadmill performance such as beta-blockers or antiretroviral therapy

Active substance abuse including ETOH

Medical or psychological instability such that subjects could not reasonably be expected to fulfill the study requirements

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677157